Integra® Miltex®
Integra® Miltex® Cleveland Oral Surgery Rongeur 5-1/4", No. 5S, Side Cutting, Jaws at 30° Angle
2manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EMH |
| Device type | Forceps, Rongeur, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-10 |
| Record revised | 2023-04-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Angle 90 ° |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22-490 | In distribution | |
| 22-481 | In distribution | |
| 22D-424 | In distribution | |
| 22D-420 | In distribution | |
| 22-484 | In distribution | |
| 22-482 | Angle 90 ° | In distribution |
| 22-494 | In distribution | |
| 22D-428 | In distribution | |
| 22D-426 | In distribution | |
| 22D-422 | In distribution | |
| 22-480 | In distribution | |
| 22-486 | In distribution | |
| 22D-432 | In distribution | |
| 22-488 | In distribution | |
| 22-492 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Buxton BioMedical | Buxton Biomedical, Inc. | 280 |
| ACE | Ace Surgical Supply Co., Inc. | 200 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 137 |
| Pomee | Pomee Corporation | 80 |
| Anmuth Medical International | Anmuth Medical International LLC | 73 |
| Forceps, Rongeur, Surgical | George Tiemann & Co. | 55 |
| HNM Medical | HNM Stainless, LLC. | 45 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 41 |
| Kohdent | Kohler Medizintechnik GmbH | 30 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 22 |
| American Medicals | American Medicals | 21 |
| Reicodent | Devemed Gmbh | 21 |
Showing 12 of 129. All products under Forceps, Rongeur, Surgical
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.